Medical dispensers are well known for the dispensing of various kinds of medicament. Inhalation devices, such as metered dose inhalers (MDI) and dry powder inhalers are known for the delivery of medicament for the treatment of respiratory disorders. Syringes, including needleless syringes are also known for the delivery of injectable medicament to a patient.
The manufacture of medical dispensers requires careful control to ensure compliance with product specifications. Similarly, the packaging, distribution and sale of medical dispensers are carefully controlled to ensure consistent product quality and security for the patient. It is common practice to mark the dispenser and any packaging therefor with various codings and serial numbers for use in checking product integrity. Widely used marking techniques include the use of visual text, machine-readable text, bar codes and dot codes.
In the event of a patient complaint which results in return of the medical dispenser or indeed in the event of a product recall for any other reason, the manufacturer employs the codings and serial numbers to check the product details. Counterfeiting is known to be a problem with medical dispensers given the often-high resale value of the product. Product marking is further employed to reduce the opportunities for counterfeiting and in particular, to make counterfeit products more readily identifiable.
Reloadable medicament dispensers are known. These typically comprise a housing defining a cavity and a medicament container which is reversibly receivable thereby. The housing and the medicament container may be sold separately or as a kit of parts. There is current interest in the development of reloadable medicament dispensers in which the housing is reasonably sophisticated in nature and comprises some sort of electronic data management capability. The reload is desirably in the form of a medicament cartridge which for cost reasons has a relatively simple form. The patient retains the sophisticated actuator housing and reloads are inserted as required.
There are a number of potential challenges associated with reloadable medicament dispensers and these have hitherto prevented their widespread use. A primary challenge is to ensure that the reload is employed with the correct actuator housing. Secondary challenges include preventing the use of out-of-date or counterfeit cartridge reloads. Tailoring the actuator housing to be only operable (e.g. mechanically operable) with the correct reload is a feasible, but expensive and therefore commercially unattractive solution to the primary challenge. Existing product marking methods can in some ways be employed to address the secondary challenges. Overall, there is a need for further developments to address these and other challenges associated with reloadable medicament dispensers.
The Applicants have now devised a solution for addressing the potential challenges associated with reloadable medicament dispensers which is of greater sophistication than presently used techniques and has significant advantages thereover. The solution involves associating a first transceiver for transmitting and receiving a data signal with the reloadable actuator housing and associating a second transceiver with the medicament container reload. The first and second transceivers are arranged such that data is transferable in two-way fashion (e.g. read/write fashion) therebetween. In typical embodiments, the first transceiver is an actively powered transceiver which forms an integral part of an electronic data management system on the housing and the second transceiver is a passive (i.e. not directly powered) transceiver. Thus, the second transceiver may for example be a magnetic or radiofrequency identifier (RFID) label and the first transceiver a reader therefor having read/write capability.
The transceiver on the medicament reload is typically marked at the time of manufacture with various product information including type of medicament, initial number of doses, date and place of manufacture and an anti-counterfeiting code. If desired, further marking can be added at the time of dispensing such as date and time of dispensing, name of the prescriber and pharmacist and identification of the patient. When the reload is inserted into the actuator housing, the marking thereon will be read by the transceiver on the housing and the electronic data management system updated. At this point, various security, product integrity and product matching with actuator checks may be conducted (e.g. for out-of-date reloads or counterfeits) and any problems flagged. If product integrity problems are detected the dispenser may automatically shutdown.
An important aspect of the present development is that it allows for two-way transfer of data between the transceiver and electronic data management system on the housing and the transceiver on the medicament reload. This gives rise to significant advantages. For example, each time the medicament dispenser is used by the patient actuation or dispensing data may be recorded and transferred to the reload. The dose count and other compliance data are therefore recordable by both the electronic data management system of the housing and on the reload. When the reload is removed from the housing, any subsequent insertion thereof can be arranged to result in a re-recognition of the reload and associated update of the electronic data management system. This can be arranged to operate even when multiple, possibly dissimilar, reloads are used with the same actuator housing. The development described herein therefore enables a sophisticated actuator with electronic data management capability to be used securely and intelligently with multiple medicament reloads over a period of time.
PCT patent application no. WO92/17231 describes a metered dose inhaler having a microelectronic assembly thereon. The medicament container includes a set of electrically conducting strips which represent information about the medicament container in digital form. The housing of the device includes electrical contact fingers which are contactable with the strips to enable reading of the information to a microelectronic memory on the housing. Read/write communication would not be possible between the fingers and the reader and the significant advantages of the present invention would therefore not be achievable with this inhaler. Furthermore, contact between the strips on the container and the electrical contact fingers is required which requires physical tailoring of the container to the housing, thereby limiting product design options.
This document also describes an embodiment in which an active (i.e. powered) microelectronic element is attached to the container.